60 Participants Needed

Electronic Decision Aid for Atrial Fibrillation

Recruiting at 1 trial location
SB
JA
Overseen ByJoel Adekanye, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electronic tool designed to assist individuals with atrial fibrillation—a condition where the heart beats irregularly—in choosing the best stroke prevention treatment. Researchers aim to determine if this electronic patient decision aid enhances treatment decisions made by patients and doctors compared to standard educational materials. Individuals diagnosed with atrial fibrillation within the past year and who have an upcoming specialist visit may find this trial suitable. Participants will either use the decision aid alongside standard information or receive only the standard information before their appointment. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve decision-making tools for future patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, if you are currently on dual antiplatelet therapy for a reason other than atrial fibrillation, you cannot participate.

What prior data suggests that this electronic patient decision aid is safe for use in stroke prevention therapy decision-making?

Research has shown that digital tools, like the electronic patient decision aid in this trial, are generally safe. These tools assist patients and doctors in making better health decisions together. Studies have found that these aids can reduce "decisional conflict," helping people feel more confident and clear about their health choices. Some evidence suggests they can improve knowledge, although this is less certain.

Past studies have not linked electronic decision aids to any safety issues. They primarily provide information rather than function as treatments like medicines or surgeries, making them very low risk. Essentially, these tools aim to support better discussions and decisions during medical visits without causing harm.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to empower patients with atrial fibrillation. Unlike traditional treatments that primarily focus on medication management and procedures, like anticoagulants or catheter ablation, this electronic decision aid provides patients with tailored information and tools to make informed decisions about their treatment options. This approach emphasizes patient engagement and shared decision-making, which could lead to better adherence to treatment plans and improved health outcomes. By integrating technology into patient education, the trial aims to enhance patients' understanding and involvement in their own care, which is a promising step forward in managing atrial fibrillation.

What evidence suggests that this electronic patient decision aid is effective for atrial fibrillation?

Research has shown that digital tools can boost patients' confidence in making health decisions. While these tools might also enhance patient knowledge, this remains less certain. In this trial, participants will receive either web-based information alone or web-based information with access to a patient decision aid. Studies have found that patient decision aids can enhance shared decision-making, enabling patients and doctors to collaborate on selecting the best treatment. For patients with atrial fibrillation, these aids could help them better understand stroke prevention options and make more informed choices.14678

Who Is on the Research Team?

SB

Stephen B Wilton, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were diagnosed with non-valvular atrial fibrillation within the last year. They can have any level of stroke risk and either be new to oral anticoagulant therapy or treated for less than three months. Participants must have a specialist visit scheduled within the next 7-30 days.

Inclusion Criteria

I have an appointment with a heart specialist between 7 to 30 days from now.
I was diagnosed with non-valvular AF less than a year ago.
I have not been on blood thinners, or was on them for less than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive either the RAPID AFib decision aid or standard educational materials before their clinic visit

1 week
1 visit (in-person)

Clinic Visit

Participants attend a clinic visit where shared decision-making is assessed

1 day
1 visit (in-person)

Follow-up

Study participation ends after completion of a post-visit survey to assess shared decision-making and therapy decisions

Immediately after clinic visit

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic patient decision aid
Trial Overview Researchers are testing an electronic decision aid designed to help patients with atrial fibrillation make informed choices about stroke prevention therapy. The study compares outcomes from using this tool plus standard educational materials against just educational materials before a doctor's visit.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Decision AidExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Servier

Industry Sponsor

Trials
55
Recruited
45,600+

Published Research Related to This Trial

An interactive decision-making aid was developed for patients with atrial fibrillation (AF) using a user-centered design approach, incorporating feedback from both experts and AF patients.
Preliminary evaluations suggest that this decision aid, which includes visualizations, could effectively help patients make informed treatment decisions regarding their AF management.
Designing for patient decision-making: Design challenges generated by patients with atrial fibrillation during evaluation of a decision aid prototype.Fanio, J., Zeng, E., Wang, B., et al.[2023]
A study involving 15 patients with atrial fibrillation and 5 clinicians revealed that while patients experienced low decisional conflict and regret regarding catheter ablation, they felt under-informed and lacked agency in the decision-making process.
Patients expressed a strong preference for an interactive, web-based decision aid that provides clear evidence and personalized risk assessments, indicating a need for tools that enhance decision quality and patient engagement in treatment choices.
'Replace uncertainty with information': shared decision-making and decision quality surrounding catheter ablation for atrial fibrillation.Reading Turchioe, M., Mangal, S., Ancker, JS., et al.[2023]
Decision aids (DAs) significantly reduce decisional conflict regarding the use of oral anticoagulants (OACs) and enhance their uptake among patients with atrial fibrillation (AF), based on a meta-analysis of 10 studies.
DAs that incorporate key elements of shared decision-making, such as clarifying options and aligning with patient preferences, are more effective in promoting OAC uptake, although their impact on adherence and the incidence of stroke and bleeding remains unclear.
Decision aids for shared decision-making and appropriate anticoagulation therapy in patients with atrial fibrillation: a systematic review and meta-analysis.Song, D., Zhou, J., Fan, T., et al.[2022]

Citations

Use of digital patient decision-support tools for atrial ...Moderate certainty evidence suggests digital patient decision-support tools reduce decisional conflict, with low certainty evidence of knowledge improvement.
Abstract 4139443: Patient Decision Aids and Encounter ...Our study assessed the comparative effectiveness of PDAs and EDAs on SDM during AF clinical encounters where stroke prevention strategies were ...
RAPID AFib Decision Aid for Stroke Prevention in Atrial ...The goal of this pilot clinical trial is to evaluate the utility of a new electronic patient decision aid for stroke prevention therapy in patients with ...
Effectiveness of shared decision making strategies for ...This study implies that using either a patient decision aid or an encounter decision aid is effective in achieving shared decision making when ...
Designing for patient decision-makingPatients with atrial fibrillation (AF) could benefit from a decision aid to compare AF treatment outcomes, risks and benefits, and alignment ...
Randomized Clinical Trial to Evaluate an Atrial Fibrillation ...We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE‐AF (Engaging ...
073 Comparative effectiveness of patient decision aids vs. ...The effect of shared decision-making for stroke prevention on treatment adherence and safety outcomes in patients with atrial fibrillation: a randomized clinica ...
Study Details | NCT04357288 | Randomized Evaluation of ...This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and ...
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